Shipping Biological Substances Category B

Shipping Biological
Substances Category B
University of Notre Dame
Risk Management & Safety
636 Grace Hall, Notre Dame
574-631-5037
Why is this training necessary?
• By law, anyone who packs, ships, transports or receives
dangerous goods must be properly trained.
• This training must be renewed every 2 years.
• The shipper bares ultimate legal responsibility and
liability for properly performing these tasks.
• Penalties for non-compliance with shipping regulations
can result in the following fines:
• Up to $250,000 and up to a year jail sentence for individuals
• Up to $500,000 per incident for organizations
Shipper’s Responsibilities
• Classification: Categorize the type of hazardous
material.
• Identification: Select the proper shipping information
from the IATA Dangerous Goods Regulations.
• Packaging: Properly pack the hazardous material for
shipment.
• Marking and Labeling: Addresses, UN number, etc.
must be on package.
• Documenting: Fill in and sign the airway bill. Maintain
records of shipments for two years.
What is a Dangerous Good?
• A dangerous good is any article or substance capable of
posing a risk to health, safety, property, or the
environment (IATA).
• A material or substance posing an unreasonable risk to
health, safety, and property when transported (DOT).
• An equivalent term is hazardous material, or hazmat.
Shipping Hazard Classes
There are nine hazard classes
• Class 1: Explosives
• Class 2: Gases
• Class 3: Flammable Liquids
• Class 6: Toxic (poisonous)
and Infectious Substances
• 6.1 Toxic Substances
• 6.2 Infectious Substances
• Class 4: Flammable Solids
• Class 7: Radioactive
• Class 5: Oxidizers and
Organic Peroxides
• Class 8: Corrosive
• Class 9: Miscellaneous
Dangerous Goods
(includes dry ice)
Class 6 & Class 9 are most commonly shipped by labs.
Shippers Declaration
• This training will allow you to ship
certain materials that do NOT
require a “Shipper’s Declaration for
Dangerous Goods”.
• If you are told that a Shipper’s
Declaration is required, RMS will
ship the package for you. You will
need to complete a Request to Ship
Hazardous Materials form and
return to RMS at [email protected]
or fax to 631-8794
Infectious Agents are Class 6.2
Dangerous Goods
• Infectious substances are known or reasonably
expected to contain pathogens. Pathogens are
defined as microorganisms (including bacteria,
viruses, rickettsiae, parasites, or fungi) or other
agents such as prions, which have the potential to
cause transmissible diseases.
• There are two major classifications when shipping
infectious substances:
• Category A
• Category B
Infectious Substance Category A
• Can only be shipped by RMS
• Infectious substances which are transported in a
form that when exposure occurs is capable of
causing permanent disability; of being life
threatening or; capable of causing fatal disease to
humans or animals.
• Example: Hepatitis B virus (cultures only)
Ebola virus
Examples of Infectious Agents Categorized as
Category A: Infectious Substance Affecting Humans
•
Bacillus anthracis (cultures only)
•
Eastern equine encephalitis virus (cultures only)
•
Brucella abortus (cultures only)
•
Escherichia coli, verotoxigenic (cultures only)
•
Brucella melitensis (cultures only)
•
Ebola virus
•
Brucella suis (cultures only)
•
Flexal virus
•
Burkholderia mallei – Pseudomonas mallei – Glanders (cultures
only)
•
Francisella tularensis (cultures only)
•
Chlamydia psittaci – avian strains (cultures only)
•
Guanarito virus
•
Clostridium botulinim (cultures only)
•
Hantaan virus
•
Coccidioides immitis (cultures only)
•
Hantaviruses causing hantavirus pulmonaty syndrome
•
Coxiella burnetii (cultures only)
•
Hendra virus
•
Crimean – Congo hemorrhagic fever virus
•
Hepatitis B virus (cultures only)
•
Dengue cirus (cultures only)
•
Herpes B virus (cultures only)
•
Human immunodeficiency virus (cultures only)
Examples of Infectious Agents Categorized as
Category A: Infectious Substance Affecting Humans
•
Highly Pathogenic avian influenza virus (cultures only)
•
Rickettsia prowazekii (cultures only)
•
Japanese Encephalitis virus (cultures only)
•
Rickettsia rickettsii (cultures only)
•
Junin virus
•
Rift Valley fever virus
•
Machipo virus
•
Russian spring-summer encephalitis virus (cultures only)
•
Marburg virus
•
Sabia virus
•
Monkeypox virus
•
Shigella dyseteriae type 1 (cultures only)
•
Mycobacterium tuberculosis (cultures only)
•
Tick-borne encephalitis virus (cultures only)
•
Nipah virus
•
Variola virus
•
Omsk hemorrhagic fever virus
•
Venezuelan equine encephalitis virus
•
Poliovirus (cultures only)
•
West Nile virus (cultures only)
•
Rabies virus
•
Yellow fever virus (cultures only)
Infectious Substance Category B
After this training you may ship these agents.
•
Category B infectious agents do not pose a risk of causing
permanent disability, life threatening or fatal disease to humans or
animals.
•
Most infectious cultures or clinical specimens are considered
Category B and are assigned UN 3373 and follow Packaging
Instruction 650.
•
Examples include:
•
•
•
•
Adenovirus
Herpes Simplex Virus (HSV – 1)
Epstein Barr Virus
Streptococcal Bacteria
Exempt Specimens
•
Definition: Human, animal, insect, or plant material which do not contain
infectious substances or substances which are unlikely to cause disease in humans or
animals and are transported for diagnostic or investigational purposes.
• Includes the following:
Excreta (urine, feces)
Blood or its components
Secreta (saliva, sweat)
Tissues and Fluids
•
Routine blood, serum, or urine samples from patients shipped to a laboratory for
routine testing are exempt only if, in your professional judgment (based on medical
history, symptoms and individual circumstances of the source) the patients have a
minimal likelihood of being infectious.
•
Specimens suspected of being infectious should be shipped as infectious agents.
•
Live animals or infected animal specimens are not considered exempt.
•
PACKAGING REQUIREMENTS FOR LIQUID SPECIMENS ARE THE SAME
AS FOR CATEGORY B (UN3373) NON-EXEMPT SPECIMENS!
Other Exempt Biological
Specimen
•
Neutralized or inactivated biological substance: Substances in a form
that any present pathogens have been neutralized or inactivated such that
they no longer pose a health risk.
•
Microorganisms which are non-pathogenic to humans or animals and
do not pose a threat to the environment.
•
Environmental Samples: (including food and water samples), which are
not considered to pose a significant risk of infection.
•
Dried blood spots: Collected by applying a drop of blood on to absorbent
material or fecal occult blood screening tests.
•
Transfusion materials: (Uninfected) Blood components which have been
collected for the purposes of transfusion of the preparation of blood
products to be used for transfusion or transplantation.
Selecting the Proper Package
• Federal regulations state that packaging used to ship
hazardous materials must be capable of performing up to
regulatory standards for ability to withstand: vibrations,
rainfall, drops, puncture, pressure, leaks, stacking, etc.
• Diligence in selecting the proper packaging will safeguard
your shipment, and reduce your liability in case of a
shipping accident.
• The outer packaging must be a cardboard box – if
shipping with dry ice, do not ship in Styrofoam boxes
that are not within cardboard. You must also complete
the Dry Ice Shipping Training
Triple Packaging System for Shipping
ALL Liquid Biological materials
1. Primary watertight, leak-proof, securely closed receptacles
(Eppendorf tube, conical, or vial) Parafilm can be used to secure
the seal of tubes. Specimen bags should be taped shut. You may
ship multiple containers in the same package.
2. Leak-proof secondary container (in case primary containment
fails) with sufficient absorbent material to completely absorb the
contents in the event of a spill.
An itemized list of contents should be placed between the
secondary container and the outer package.
3. Durable outer container (box/packaging): Styrofoam boxes
should be placed within a durable cardboard box.
Triple Packaging System for Shipping
ALL Solid Biological materials
1. Primary sift-proof/ leakproof, securely closed receptacles
(Eppendorf tube, conical, or vial, ziplock) Specimen bags should
be taped shut. You may ship multiple containers in the same
package.
2. Leak-proof secondary container (in case primary containment
fails) with sufficient packing to minimize shifting of primary
package.
An itemized list of contents should be placed between the
secondary container and the outer package.
3. Durable outer container (box/packaging): Styrofoam boxes
should be placed within a durable cardboard box, if shipping with
dry ice.
Packing for Category B
According to packing instruction 650, your package must:
•
Withstand 95kPa of pressure and temperatures between 40°F and 130°F.
•
Contain no more than 4 liters in the outer packaging, excluding ice.
•
Include an itemized list of contents between the secondary packaging and
outer packaging
•
Be marked with the proper shipping name, “Biological Substance,
Category B”.
•
Display the name and telephone number of a responsible contact person
on the exterior.
•
Be labeled with the UN3373 marking.
Includes triple packaging example
Name and Telephone number of responsible party. This may included
on air waybill if the air waybill is attached to box.
Dr. John Doe
University of Notre Dame
100 Galvin Life Sciences
Notre Dame, IN 46556
Packaging: Exempt
Human/Animal Specimens
• Human or animal materials being transported for diagnostic or
investigational purposes that are not believed to harbor
infectious agents are exempt from dangerous goods regulations.
• If there is more than a minimal likelihood that a specimen is
infectious, it should be shipped as an infectious agent.
• Specimens should be shipped using the triple packaging
system.
• The outer package must be durable enough for its intended use
with at least one side measuring 100 x 100 mm (~4 square
inches)
• The outer package must be marked with “Exempt human
specimen” or “Exempt animal specimen”.
Specimens in Fixatives
• Specimens in formaldehyde, glutaraldhyde, or any
other chemical fixative may be shipped as long as
the amount of chemical is 30 ml or less in each
individual container. Need a special label from
RMS.
• Samples with more than 30 ml of fixative must be
shipped as a chemical hazard by RMS.
Outer Package
• IMPORTANT: Dangerous goods (including dry ice)
cannot be shipped in FedEx packaging or left in FedEx
Drop Boxes.
• If you choose to reuse a box, completely obliterate all
unnecessary markings such as addresses, hazard labels,
FedEx or other courier labels, barcodes, etc.
• Only reuse a box if you can personally verify it is not
contaminated and its integrity is intact.
• A box should not be reused if it is torn, cut, stained or if
the insulation is cracked or broken.
International Shipments
• Contact RMS for assistance with shipping
internationally.
• International shipments require additional
paperwork, including a Commercial Invoice, and
possibly other forms depending on the contents.
• We can either ship the package for you, or walk you
through the correct steps to ensure that it arrives at
its destination with no delays.
Documentation
• Training Records: Must be renewed every two years.
• The completed airbill is your documentation of the
shipment. Keep a copy for your records.
• In addition to the airbill, keep documentation stating
exactly what you shipped in the package.
• Records of shipments should be maintained for two
years following the shipment.
DOT Security Awareness
consists of…
• Understanding the nature of security risks.
• Recognizing potential security risks.
• Methods to address and reduce these risks.
• Actions to take in the event of a security breach.
DOT Security Awareness
• Remember… many materials that are classified as
hazardous are essential products in industry, but
potentially deadly weapons in the hands of a terrorist.
• It is important to understand that certain classifications
of Dangerous Goods (hazardous materials) can be
intentionally misused for terrorist type activities.
• The most likely terrorist threats are external (nonuniversity employees), but there have been instances of
“inside jobs” when it comes to criminal activities.
DOT Security Awareness
• An improperly labeled package, poor package
condition, or incomplete documentation (e.g. airway
bill and shipping address on package not matching)
may be perceived as a suspicious package.
• This validates the necessity for proper training,
recordkeeping, labeling and packaging of DG
shipments.
DOT Security Awareness
• Be aware of your surroundings and the people you
are dealing with when transporting or offering a
shipment of processing.
• If you feel there is any suspicious activity,
immediately report it to NDSP at 631-5555 and then
notify your PI/Supervisor.
Training Quiz
• To receive a certificate, you must take and pass the
quiz at the link below. Risk Management and Safety
will notify you if you failed. If you passed you will
receive a certificate in campus mail.
Training quiz